Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer

NCT ID: NCT00976456

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 271 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-10-31

Brief Summary

Multi-center, open, randomized (parallel) and comparative phase III.

Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.

Arm A: Bevacizumab + pemetrexed

Arm B: Bevacizumab + pemetrexed + carboplatin

Detailed Description

Primary:

• Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival

Secondary:

• To assess the efficacy of bevacizumab as measured by overall response rate and overall survival.
• To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin.
• To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13
• To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment
• To assess patient's outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score

Conditions

Non-squamous Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab + Pemetrexed

Bevacizumab + Pemetrexed

Group Type: ACTIVE_COMPARATOR

Bevacizumab + Pemetrexed

Intervention Type: DRUG

Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks

Bevacizumab + Pemetrexed + Carboplatin

Bevacizumab + Pemetrexed + Carboplatin

Group Type: ACTIVE_COMPARATOR

Bevacizumab + Pemetrexed + Carboplatin

Intervention Type: DRUG

Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks

Interventions

Bevacizumab + Pemetrexed

Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks

Intervention Type: DRUG

Bevacizumab + Pemetrexed + Carboplatin

Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks

Intervention Type: DRUG

Other Intervention Names

Avastin®; ALIMTA®; Avastin®; ALIMTA®; Carboplatin

Eligibility Criteria

Inclusion Criteria

• Stage IIIb and IV NSCLC, excluded squamous cell NSCLC
• Age ≥ 65 years
• ECOG 0-2

Exclusion Criteria

• Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
• History of haemoptysis
• Evidence of tumour invading major blood vessels on imaging
• Radiotherapy within 28 days prior to enrolment
• Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
• Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed
• Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, CHF NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
• Non-healing wound, active peptic ulcer or bone fracture
• History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

PD Dr. med. Wolfgang Schuette

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. med. Wolfgang Schuette

PhD MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wolfgang Schuette, PhD MD.

Role: STUDY_CHAIR

Krankenhaus Martha-Maria Halle-Doelau

Locations

Krankenhaus Martha-Maria Halle-Doelau

Halle, , Germany

Countries

Germany

Other Identifiers

ML21896

Identifier Type: -

Identifier Source: secondary_id

65 plus

Identifier Type: -

Identifier Source: org_study_id